Acoustic shock wave therapeutic methods

ABSTRACT

A method of modulating glandular secretions by administering acoustic shock waves to a reflexology zone has been discovered. In one preferred embodiment, a treatment method achieves one or more of a) modulating blood sugar levels, b) stimulating insulin production levels or c) normalizing A1C levels by administering acoustic shock waves to a reflexology zone or region of a patient. The treatment method further has the steps of: activating acoustic shock waves of an acoustic shock wave generator to emit acoustic shock waves; subjecting the reflexology zone to acoustic shock waves stimulating the pancreas to have a modulated response wherein the modulated response is one of an adjustment in blood sugar levels or insulin production and release or normalizing A1C levels which increases low level output, decreases high level output or stabilizes erratic output; and wherein the emitted acoustic shock waves are focused or unfocused.

RELATED APPLICATIONS

The present invention is a continuation in part of co-pendingapplications U.S. Ser. No. 15/984,505 entitled “Improved Acoustic ShockWave Therapeutic Methods” filed on May 21, 2018 and U.S. Ser. No.15/131,303 entitled “Treatments For Blood Sugar Levels And Muscle TissueOptimization Using Extracorporeal Acoustic Shock Waves” filed on Apr.18, 2016 and published on Oct. 19, 2017 as US 2017/0296427 A1.

TECHNICAL FIELD

The present invention relates to an improved treatment method ofutilizing acoustic shock waves to modulate blood sugar levels, stimulateinsulin production and normalize A1C levels.

BACKGROUND OF THE INVENTION

In U.S. Pat. No. 7,470,240 B2, entitled “Pressure Pulse/Shock WaveTherapy Methods And An Apparatus For Conducting The TherapeuticMethods”, is disclosed a novel use of unfocused shock waves to stimulatea cellular substance. From this patent a family of treatment patentsevolved. The list includes U.S. Pat. No. 7,841,995; U.S. Pat. No.7,883,482; U.S. Pat. No. 7,905,845 all divisional applications; and U.S.Pat. No. 7,507,213 entitled “Pressure Pulse/Shock Wave Therapy MethodsFor Organs”; U.S. Pat. No. 7,544,171 B2 entitled “Methods for PromotingNerve Regeneration and Neuronal Growth and Elongation”; U.S. Pat. No.7,988,648 B2 entitled “Pancreas Regeneration Treatment For DiabeticsUsing Extracorporeal Acoustic Shock Waves”; all teaching a new usefulway to deliver acoustic shock waves to achieve a healing response. Eachof these patents are incorporated herein by reference in their entirety.In addition, patents U.S. Pat. Nos. 8,257,282 and 8,535,249 for thedevice to perform these methods by delivering low energy unfocusedacoustic shock waves to the cellular tissue being treated.

During this inventive research, the inventors disclosed the use ofacoustic shock waves could be beneficial to controlling blood sugarlevels. Co-pending US publication 2017/0296427 A1 filed Apr. 18, 2016entitled “Treatments For Blood Sugar Levels And Muscle TissueOptimization Using Extracorporeal Acoustic Shock Waves” and publishedOct. 19, 2017 teaches a heretofore never used approach to treatextremities to control bold sugar levels and optimize muscle tissueregeneration. The subject matter of that pending application is beingincorporated herein by reference in its entirety.

While this large volume of research has been rewarded by the granting ofnumerous patents, much new work has been evolving as the understandingof the technology is being applied. It is in this latest work that some,heretofore, unknown improvements and refinements have been discoveredthat were hidden from and unappreciated by scientists in this field. Inparticular, the use of acoustic shock waves to regulate and in somecases stimulate glandular hormonal secretions or modulate glandularhormonal secretions.

In recently filed co-pending U.S. patent application Ser. No. 15/984,505filed May 21, 2018 entitled “Improved Acoustic Shock Wave TherapeuticMethods” which is also being incorporated herein by reference in itsentirety discloses a method of modulating glandular secretions byadministering acoustic shock waves to a gland, includes the steps ofactivating acoustic shock waves of an acoustic shock wave generator toemit acoustic shock waves and subjecting the gland to acoustic shockwaves stimulating the gland to have a modulated response. The modulatedresponse is one of an adjustment in hormonal release which increases lowlevel output, decreases high level output or stabilizes erratic output.

The present invention has recently and quite unexpectedly discovered animproved treatment therapy that achieves all the objectives of theearlier work in a newly discovered and remarkably efficient way.

The present invention directs acoustic shock waves to reflexologyregions to achieve a desired response as disclosed below.

SUMMARY OF THE INVENTION

A method of modulating glandular secretions by administering acousticshock waves to a reflexology zone or region has been discovered. In onepreferred embodiment, a treatment method achieves one or more of a)modulating blood sugar levels, b) stimulating insulin production levelsor c) normalizing A1C levels by using the step of administering acousticshock waves to a reflexology zone or region. The treatment methodfurther has the steps of: activating acoustic shock waves of an acousticshock wave generator to emit acoustic shock waves; subjecting thereflexology zone to acoustic shock waves stimulating the pancreas tohave a modulated response wherein the modulated response is one of anadjustment in blood sugar levels or insulin production and release ornormalizing A1C levels which increases low level output, decreases highlevel output or stabilizes erratic output; and wherein the emittedacoustic shock waves are focused or unfocused acoustic shock waves.

The reflexology zone or region underlies the patient's skin in a regionof a foot or hand. The shock wave generator is acoustically coupled tothe patient's skin using a coupling gel or liquid. The reflexology zonefor the pancreas is a region of the foot located in a middle of aninside arch of each foot. Additionally, the reflexology zone for thepancreas is a region of the right hand in the fatty part below the indexfinger and a region of the left hand below the middle finger close tothe wrist. The stimulating of the pancreas causes a release of nitricoxide, secretion of digestive enzymes, hormones and other fluidsincluding insulin. The stimulating of the pancreas also causes a releaseof growth factors including, but not limited to VEGF. The stimulating ofthe pancreas can cause new blood vessels to be created increasingvascularization. The treatment method preferably can be repeated one ormore times. Each treatment emits 100-3000 acoustic waves to thereflexology region, preferably 500 to 2000. These emitted acoustic shockwaves are preferably low energy soft waves. The low energy soft waveshave an energy density in the range of 0.01 mJ/mm2 to 0.4 mJ/mm2,preferably the low energy soft waves have an energy density in the rangeof 0.04 mJ/mm2 to 0.3 mJ/mm square.

Each subjected reflexology zone receives between 100 and 2000 acousticshock waves per therapy session. These therapy sessions can be repeatedmultiple times over several weeks or months to control the desiredresults or responses.

The modulated blood sugar level response is a decrease in the bloodsugar level wherein the patient was exhibiting high levels of bloodsugar. The response to stimulating insulin production is an increase ininsulin release wherein the patient was exhibiting low levels of insulinproduction. The response of normalizing A1C levels is a decrease inspikes wherein the patient was exhibiting high levels of A1C spikes.

It is believed the acoustic shock waves can be spherical, radial,convergent, divergent, planar, near planar, focused or unfocused wavesemitted from a source with or without a lens that can be one ofelectrohydraulic, electromagnetic, piezoelectric, ballistic, radial orany type acoustic wave that meets the energy parameters referenced inthis application. The acoustic shock waves can be administeredinvasively or non-invasively to the reflexology region, most preferablynon-invasively.

Definitions

“A1C level”: refers to the Hemoglobin A1c (HbA1c) Test for Diabetes. Thehemoglobin A1c test measures average blood glucose over the past 2 to 3months. It's also called HbA1c, glycated hemoglobin test, andglycohemoglobin. People who have diabetes need this test regularly tosee if their levels are staying within range. It is used to determine ifthere is a need to adjust a person's diabetes medicines. The A1c test isalso used to diagnose diabetes.

“Adrenal Gland”: The adrenal glands (also known as suprarenal glands)are endocrine glands that produce a variety of hormones includingadrenaline and the steroids aldosterone and cortisol. They are foundabove the kidneys. Each gland has an outer cortex which produces steroidhormones and an inner medulla.

“Adrenaline”: Adrenaline, also known as adrenalin or epinephrine, is ahormone, neurotransmitter, and medication. Epinephrine is normallyproduced by both the adrenal glands and certain neurons. It plays animportant role in the fight-or-flight response by increasing blood flowto muscles, output of the heart, pupil dilation, and blood sugar.

“Aldosterone”: Aldosterone, the main mineralocorticoid hormone, is asteroid hormone produced by the zona glomerulosa of the adrenal cortexin the adrenal gland. It is essential for sodium conservation in thekidney, salivary glands, sweat glands and colon. It plays a central rolein the homeostatic regulation of blood pressure, plasma sodium (Na+),and potassium (K+) levels. It does so mainly by acting on themineralocorticoid receptors in the distal tubules and collecting ductsof the nephron. It influences the reabsorption of sodium and excretionof potassium (from and into the tubular fluids, respectively) of thekidney, thereby indirectly influencing water retention or loss, bloodpressure and blood volume. When dysregulated, aldosterone is pathogenicand contributes to the development and progression of cardiovascular andrenal disease.

“Blood sugar level”: The blood sugar level, blood sugar concentration,or blood glucose level is the amount of glucose present in the blood ofhumans and other animals. Glucose is a simple sugar and approximately 4grams of glucose are present in the blood of a 70-kilogram (150 lb)human at all times. The body tightly regulates blood glucose levels as apart of metabolic homeostasis. Glucose is stored in skeletal muscle andliver cells in the form of glycogen; in fasted individuals, bloodglucose is maintained at a constant level at the expense of glycogenstores in the liver and skeletal muscle. Cellular glucose uptake isprimarily regulated by insulin, a hormone produced in the pancreas.Blood sugar levels outside the normal range may be an indicator of amedical condition. A persistently high level is referred to ashyperglycemia; low levels are referred to as hypoglycemia.

“Cortisol”: Cortisol is a steroid hormone, in the glucocorticoid classof hormones. When used as a medication, it is known as hydrocortisone.It is produced in humans by the zona fasciculata of the adrenal cortexwithin the adrenal gland. It is released in response to stress and lowblood-glucose concentration. It functions to increase blood sugarthrough gluconeogenesis, to suppress the immune system, and to aid inthe metabolism of fat, protein, and carbohydrates. It also decreasesbone formation.

A “curved emitter” is an emitter having a curved reflecting (orfocusing) or emitting surface and includes, but is not limited to,emitters having ellipsoidal, parabolic, quasi parabolic (generalparaboloid) or spherical reflector/reflecting or emitting elements.Curved emitters having a curved reflecting or focusing element generallyproduce waves having focused wave fronts, while curved emitters having acurved emitting surfaces generally produce wave having divergent wavefronts.

“Divergent waves” in the context of the present invention are all waveswhich are not focused and are not plane or nearly plane. Divergent wavesalso include waves which only seem to have a focus or source from whichthe waves are transmitted. The wave fronts of divergent waves havedivergent characteristics. Divergent waves can be created in manydifferent ways, for example: A focused wave will become divergent onceit has passed through the focal point. Spherical waves are also includedin this definition of divergent waves and have wave fronts withdivergent characteristics.

“Estrogen”: A female steroid hormone that is produced by the ovariesand, in lesser amounts, by the adrenal cortex, placenta, and maletestes. Estrogen helps control and guide sexual development, includingthe physical changes associated with puberty. It also influences thecourse of ovulation in the monthly menstrual cycle, lactation afterpregnancy, aspects of mood, and the aging process. Production ofestrogen changes naturally over the female lifespan, reaching adultlevels with the onset of puberty (menarche) and decreasing in middle ageuntil the onset of menopause. Estrogen deficiency can lead to lack ofmenstruation (amenorrhea), persistent difficulties associated withmenopause (such as mood swings and vaginal dryness), and osteoporosis inolder age. In cases of estrogen deficiency, natural and syntheticestrogen preparations may be prescribed. Estrogen is also a component ofmany oral contraceptives. An overabundance of estrogen in men causesdevelopment of female secondary sexual characteristics (feminization),such as enlargement of breast tissue.

“extracorporeal” means occurring or based outside the living body.

A “generalized paraboloid” according to the present invention is also athree-dimensional bowl. In two dimensions (in Cartesian coordinates, xand y) the formula yn=2px [with n being ≠2, but being greater than about1.2 and smaller than 2, or greater than 2 but smaller than about 2.8].In a generalized paraboloid, the characteristics of the wave frontscreated by electrodes located within the generalized paraboloid may becorrected by the selection of (p (−z,+z)), with z being a measure forthe burn down of an electrode, and n, so that phenomena including, butnot limited to, burn down of the tip of an electrode (−z,+z) and/ordisturbances caused by diffraction at the aperture of the paraboloid arecompensated for.

“Hormone”: A hormone is any member of a class of signaling moleculesproduced by glands in multicellular organisms that are transported bythe circulatory system to target distant organs to regulate physiologyand behaviour. Hormones have diverse chemical structures, mainly of 3classes: eicosanoids, steroids, and amino acid/protein derivatives(amines, peptides, and proteins). The glands that secrete hormonescomprise the endocrine signaling system. The term hormone is sometimesextended to include chemicals produced by cells that affect the samecell (autocrine or intracrine signalling) or nearby cells (paracrinesignalling). Hormones are used to communicate between organs and tissuesfor physiological regulation and behavioral activities, such asdigestion, metabolism, respiration, tissue function, sensory perception,sleep, excretion, lactation, stress, growth and development, movement,reproduction, and mood. Hormones affect distant cells by binding tospecific receptor proteins in the target cell resulting in a change incell function. When a hormone binds to the receptor, it results in theactivation of a signal transduction pathway that typically activatesgene transcription resulting in increased expression of target proteins;non-genomic effects are more rapid, and can be synergistic with genomiceffects. Amino acid-based hormones (amines and peptide or proteinhormones) are water-soluble and act on the surface of target cells viasecond messengers; steroid hormones, being lipid-soluble, move throughthe plasma membranes of target cells (both cytoplasmic and nuclear) toact within their nuclei. Hormone secretion may occur in many tissues.Endocrine glands are the cardinal example, but specialized cells invarious other organs also secrete hormones. Hormone secretion occurs inresponse to specific biochemical signals from a wide range of regulatorysystems. For instance, serum calcium concentration affects parathyroidhormone synthesis; blood sugar (serum glucose concentration) affectsinsulin synthesis; and because the outputs of the stomach and exocrinepancreas (the amounts of gastric juice and pancreatic juice) become theinput of the small intestine, the small intestine secretes hormones tostimulate or inhibit the stomach and pancreas based on how busy it is.Regulation of hormone synthesis of gonadal hormones, adrenocorticalhormones, and thyroid hormones is often dependent on complex sets ofdirect influence and feedback interactions involving thehypothalamic-pituitary-adrenal (HPA), -gonadal (HPG), and -thyroid (HPT)axes. Upon secretion, certain hormones, including protein hormones andcatecholamines, are water-soluble and are thus readily transportedthrough the circulatory system. Other hormones, including steroid andthyroid hormones, are lipid-soluble; to allow for their widespreaddistribution, these hormones must bond to carrier plasma glycoproteins(e.g., thyroxine-binding globulin (TBG)) to form ligand-proteincomplexes. Some hormones are completely active when released into thebloodstream (as is the case for insulin and growth hormones), whileothers are prohormones that must be activated in specific cells througha series of activation steps that are commonly highly regulated. Theendocrine system secretes hormones directly into the bloodstreamtypically into fenestrated capillaries, whereas the exocrine systemsecretes its hormones indirectly using ducts. Hormones with paracrinefunction diffuse through the interstitial spaces to nearby targettissue.

“Hypothalamus”: The hypothalamus is a portion of the brain that containsa number of small nuclei with a variety of functions. One of the mostimportant functions of the hypothalamus is to link the nervous system tothe endocrine system via the pituitary gland (hypophysis). Thehypothalamus is located below the thalamus and is part of the limbicsystem.

“Insulin”: is a hormone made by the pancreas that allows your body touse sugar, glucose, from carbohydrates in the food that is eaten forenergy or to store glucose for future use. Insulin helps keeps bloodsugar levels from getting too high (hyperglycemia) or too low(hypoglycemia).

“Melatonin”: Melatonin, also known as N-acetyl-5-methoxy tryptamine, isa hormone that is produced by the pineal gland in animals and regulatessleep and wakefulness. In animals, melatonin is involved in theentrainment (synchronization) of the circadian rhythms includingsleep-wake timing, blood pressure regulation, seasonal reproduction, andmany others. Many of its biological effects in animals are producedthrough activation of melatonin receptors, while others are due to itsrole as an antioxidant, with a particular role in the protection ofnuclear and mitochondrial DNA.

A “paraboloid” according to the present invention is a three-dimensionalreflecting bowl. In two dimensions (in Cartesian coordinates, x and y)the formula y2=2px, wherein p/2 is the distance of the focal point ofthe paraboloid from its apex, defines the paraboloid. Rotation of thetwo-dimensional figure defined by this formula around its longitudinalaxis generates a de facto paraboloid.

“Parathyroid”: Parathyroid glands are small endocrine glands in the neckof humans and other tetrapods that produce parathyroid hormone. Humansusually have four parathyroid glands, variably located on the back ofthe thyroid gland. Parathyroid hormone and calcitonin (one of thehormones made by the thyroid gland) have key roles in regulating theamount of calcium in the blood and within the bones.

“Parathyroid Hormone”: Parathyroid hormone (PTH), also calledparathormone or parathyrin, is a hormone secreted by the parathyroidglands that is important in bone remodeling, which is an ongoing processin which bone tissue is alternately resorbed and rebuilt over time. PTHis secreted in response to low blood serum calcium (Ca2+) levels. PTHindirectly stimulates osteoclast activity within bone marrow, in aneffort to release more ionic calcium (Ca2+) into the blood to elevateserum calcium (Ca2+) levels. The bones act as a (metaphorical) “bank ofcalcium” from which the body can make “withdrawals” as needed to keepthe amount of calcium in the blood at appropriate levels despite theever-present challenges of metabolism, stress, and nutritionalvariations. PTH is “a key that unlocks the bank vault” to remove thecalcium. In consequence, PTH is vital to health, and health problemsthat yield too little or too much PTH (such as hypoparathyroidism,hyperparathyroidism, or paraneoplastic syndromes) can wreak havoc in theform of bone disease, hypocalcaemia, and hypercalcaemia.

“Pineal body”: Pineal gland, also called conarium, epiphysis cerebri,pineal organ, or pineal body, endocrine gland. The pineal gland is asmall endocrine gland in the vertebrate brain. The pineal gland producesmelatonin, a serotonin-derived hormone which modulates sleep patterns inboth circadian and seasonal cycles. The shape of the gland resembles apine cone, hence its name. The pineal gland is located in theepithalamus, near the center of the brain, between the two hemispheres,tucked in a groove where the two halves of the thalamus join.

“Pituitary gland”: In vertebrate anatomy, the pituitary gland, orhypophysis, is an endocrine gland about the size of a pea and weighing0.5 grams (0.018 oz) in humans. It is a protrusion off the bottom of thehypothalamus at the base of the brain. The hypophysis rests upon thehypophysial fossa of the sphenoid bone in the center of the middlecranial fossa and is surrounded by a small bony cavity (sella turcica)covered by a dural fold (diaphragma sellae). The anterior pituitary (oradenohypophysis) is a lobe of the gland that regulates severalphysiological processes (including stress, growth, reproduction, andlactation). The intermediate lobe synthesizes and secretesmelanocyte-stimulating hormone. The posterior pituitary (orneurohypophysis) is a lobe of the gland that is functionally connectedto the hypothalamus by the median eminence via a small tube called thepituitary stalk (also called the infundibular stalk or theinfundibulum). Hormones secreted from the pituitary gland help control:growth, blood pressure, management of energy, all functions of the sexorgans, thyroid glands and metabolism as well as some aspects ofpregnancy, childbirth, nursing, water/salt concentration at the kidneys,temperature regulation and pain relief.

“Plane waves” are sometimes also called flat or even waves. Their wavefronts have plane characteristics (also called even or parallelcharacteristics). The amplitude in a wave front is constant and the“curvature” is flat (that is why these waves are sometimes called flatwaves). Plane waves do not have a focus to which their fronts move(focused) or from which the fronts are emitted (divergent). “Nearlyplane waves” also do not have a focus to which their fronts move(focused) or from which the fronts are emitted (divergent). Theamplitude of their wave fronts (having “nearly plane” characteristics)is approximating the constancy of plain waves. “Nearly plane” waves canbe emitted by generators having pressure pulse/shock wave generatingelements with flat emitters or curved emitters. Curved emitters maycomprise a generalized paraboloid that allows waves having nearly planecharacteristics to be emitted.

A “pressure pulse” according to the present invention is an acousticpulse which includes several cycles of positive and negative pressure.The amplitude of the positive part of such a cycle should be above about0.1 MPa and its time duration is from below a microsecond to about asecond. Rise times of the positive part of the first pressure cycle maybe in the range of nano-seconds (ns) up to some milli-seconds (ms). Veryfast pressure pulses are called shock waves. Shock waves used in medicalapplications do have amplitudes above 0.1 MPa and rise times of theamplitude are below 100 ns. The duration of a shock wave is typicallybelow 1-3 micro-seconds (μs) for the positive part of a cycle andtypically above some micro-seconds for the negative part of a cycle.

“Reflexology zone” as used herein means an area or pressure point on thefeet or hands that are access pathways to every organ, gland, muscle,etc. These pathways between pressure points and other parts of the bodyare thought to be connected via the nervous system and that aneurological relationship exists between the skin and the internalorgans, and that the whole nervous system adjusts to a stimulus.According to reflexology theory, application of pressure to feet, hands,or ears sends a calming message from the peripheral nerves in theseextremities to the central nervous system, which in turn signals thebody to adjust the tension level. This enhances overall relaxation,removes stress, brings internal organs and their systems into a state ofoptimum functioning, and increases blood supply which brings additionaloxygen and nutrients to cells and enhances waste removal. It positivelyaffects the circulatory, respiratory, endocrine, immune, andneuropeptide systems in the body.

“Reproductive glands” include ovaries and testes: A woman's 2 ovariesare located on each side of the uterus, just below the opening of thefallopian tubes (tubes that extend from the uterus to near the ovaries).The ovaries contain the egg cells needed for reproduction. They alsomake estrogen and progesterone. These affect many of the femalecharacteristics and reproductive functions. Estrogens also play animportant role in bone health and strength. The levels of estrogen andprogesterone are controlled by certain hormones made by the pituitarygland. The testes are oval-shaped organs that hang suspended in a pouchof skin (scrotum) outside the male body. The testes are the site ofsperm production. They also make testosterone and other hormones. Theseaffect many of the male characteristics and support sperm production.Testosterone also plays an important role in bone health and strength.

“Shock Wave”: As used herein is defined by Camilo Perez, Hong Chen, andThomas J. Matula; Center for Industrial and Medical Ultrasound, AppliedPhysics Laboratory, University of Washington, 1013 NE 40th Street,Seattle, Wash. 98105; Maria Karzova and Vera A. Khokhlovab; Departmentof Acoustics, Faculty of Physics, Moscow State University, Moscow119991, Russia; (Received 9 Oct. 2012; revised 16 Apr. 2013; accepted 1May 2013) in their publication, “Acoustic field characterization of theDuolith: Measurements and modeling of a clinical shock wave therapydevice”; incorporated by reference herein in its entirety.

“Testosterone”: Testosterone is the primary male sex hormone and ananabolic steroid. In male humans, testosterone plays a key role in thedevelopment of male reproductive tissues such as testes and prostate, aswell as promoting secondary sexual characteristics such as increasedmuscle and bone mass, and the growth of body hair. In addition,testosterone is involved in health and well-being, and the prevention ofosteoporosis. Insufficient levels of testosterone in men may lead toabnormalities including frailty and bone loss. Testosterone is a steroidfrom the androstane class containing a keto and hydroxyl groups at thethree and seventeen positions respectively. It is biosynthesized inseveral steps from cholesterol and is converted in the liver to inactivemetabolites. It exerts its action through binding to and activation ofthe androgen receptor. In humans and most other vertebrates,testosterone is secreted primarily by the testicles of males and, to alesser extent, the ovaries of females. On average, in adult males,levels of testosterone are about 7 to 8 times as great as in adultfemales. As the metabolism of testosterone in males is greater, thedaily production is about 20 times greater in men. Females are also moresensitive to the hormone.

“Thymus”: The thymus is a specialized primary lymphoid organ of theimmune system. Within the thymus, T cells mature. T cells are criticalto the adaptive immune system, where the body adapts specifically toforeign invaders. The thymus is composed of two identical lobes and islocated anatomically in the anterior superior mediastinum, in front ofthe heart and behind the sternum. Histologically, each lobe of thethymus can be divided into a central medulla and a peripheral cortexwhich is surrounded by an outer capsule. The cortex and medulla playdifferent roles in the development of T cells. Cells in the thymus canbe divided into thymic stromal cells and cells of hematopoietic origin(derived from bone marrow resident hematopoietic stem cells). DevelopingT cells are referred to as thymocytes and are of hematopoietic origin.Stromal cells include epithelial cells of the thymic cortex and medulla,and dendritic cells. The thymus provides an inductive environment fordevelopment of T cells from hematopoietic progenitor cells. In addition,thymic stromal cells allow for the selection of a functional andself-tolerant T cell repertoire. Therefore, one of the most importantroles of the thymus is the induction of central tolerance. The thymus islargest and most active during the neonatal and pre-adolescent periods.By the early teens, the thymus begins to atrophy and thymic stroma ismostly replaced by adipose (fat) tissue. Nevertheless, residual Tlymphopoiesis continues throughout adult life.

“Thyroid”: The thyroid gland, or simply the thyroid, is an endocrinegland in the neck, consisting of two lobes connected by an isthmus. Itis found at the front of the neck, below the Adam's apple. The thyroidgland secretes thyroid hormones, which primarily influence the metabolicrate and protein synthesis. The hormones also have many other effectsincluding those on development. The thyroid hormones triiodothyronine(T3) and thyroxine (T4) are created from iodine and tyrosine. Thethyroid also produces the hormone calcitonin, which plays a role incalcium homeostasis. Hormonal output from the thyroid is regulated bythyroid-stimulating hormone (TSH) secreted from the anterior pituitarygland, which itself is regulated by thyrotropin-releasing hormone (TRH)produced by the hypothalamus. The thyroid may be affected by severaldiseases. Hyperthyroidism occurs when the gland produces excessiveamounts of thyroid hormones, the most common cause being Graves'disease, an autoimmune disorder. In contrast, hypothyroidism is a stateof insufficient thyroid hormone production. Worldwide, the most commoncause is iodine deficiency. Thyroid hormones are important fordevelopment, and hypothyroidism secondary to iodine deficiency remainsthe leading cause of preventable intellectual disability. Iniodine-sufficient regions, the most common cause of hypothyroidism isHashimoto's thyroiditis, also an autoimmune disorder. In addition, thethyroid gland may also develop several types of nodules and cancer.

Waves/wave fronts described as being “focused” or “having focusingcharacteristics” means in the context of the present invention that therespective waves or wave fronts are traveling and increase theiramplitude in direction of the focal point. Per definition the energy ofthe wave will be at a maximum in the focal point or, if there is a focalshift in this point, the energy is at a maximum near the geometricalfocal point. Both the maximum energy and the maximal pressure amplitudemay be used to define the focal point.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described by way of example and with reference tothe accompanying drawings in which:

FIG. 1 is a simplified depiction of a pressure pulse/shock wave (PP/SW)generator with focusing wave characteristics.

FIG. 2 is a simplified depiction of a pressure pulse/shock wavegenerator with plane wave characteristics.

FIG. 3 is a simplified depiction of a pressure pulse/shock wavegenerator with divergent wave characteristics.

FIG. 4a is a simplified depiction of a pressure pulse/shock wavegenerator having a focusing element in the form of an ellipsoid. Thewaves generated are focused.

FIG. 4b is a simplified depiction of a pressure pulse/shock wavegenerator having a parabolic reflector element and generating waves thatare disturbed plane.

FIG. 4c is a simplified depiction of a pressure pulse/shock wavegenerator having a quasi parabolic reflector element (generalizedparaboloid) and generating waves that are nearly plane/have nearly planecharacteristics.

FIG. 4d is a simplified graphic depiction of a generalized paraboloidwith better focusing characteristic than a paraboloid in which n=2. Theelectrode usage is shown. The generalized paraboloid, which is aninterpolation (optimization) between two optimized paraboloids for a newelectrode and for a used (burned down) electrode is also shown.

FIG. 5 is a simplified depiction of a pressure pulse/shock wavegenerator being connected to a control/power supply unit.

FIG. 6 is a simplified depiction of a pressure pulse/shock wavegenerator comprising a flat EMSE (electromagnetic shock wave emitter)coil system to generate nearly plane waves as well as an acoustic lens.Convergent wave fronts are leaving the housing via an exit window.

FIG. 7 is a simplified depiction of a pressure pulse/shock wavegenerator having a flat EMSE coil system to generate nearly plane waves.The generator has no reflecting or focusing element. As a result, thepressure pulse/shock waves are leaving the housing via the exit windowunfocused having nearly plane wave characteristics.

FIG. 8 is a simplified depiction of a pressure pulse/shock wavegenerator having a flat piezoceramic plate equipped with a single ornumerous individual piezoceramic elements to generate plane waveswithout a reflecting or focusing element. As a result, the pressurepulse/shock waves are leaving the housing via the exit window unfocusedhaving nearly plane wave characteristics.

FIG. 9 is a simplified depiction of a pressure pulse/shock wavegenerator having a cylindrical EMSE system and a triangular shapedreflecting element to generate plane waves. As a result, the pressurepulse/shock waves are leaving the housing via the exit window unfocusedhaving nearly plane wave characteristics.

FIG. 10 shows an exemplary shock wave generator device.

FIG. 11 shows the shock wave generator device directed at a reflexologyzone on a foot of a patient.

FIG. 12 shows the shock wave generator device directed at a reflexologyzone on a hand of a patient.

FIG. 13 shows a schematic view showing general reflexology locations ofthe foot in the human body.

FIG. 14 shows a schematic view showing general reflexology locations ofthe hand in the human body.

DETAILED DESCRIPTION OF THE INVENTION

The present methodology uses an acoustic shock wave form directed tospecific reflexology zones to stimulate a modulated response.

In the Extracorporeal Shock wave method of treating a patient at atarget site on the anatomy. In this invention, the term target siterefers to a reflexology location for a specific gland and the tissue ofthe hand or foot at the desired reflexology zone or region being in thepath of the shock wave applicator. The patient is placed in a convenientorientation to permit the source of the emitted waves to most directlysend the waves to the target site to initiate shock wave stimulation ofthe target area. Assuming the target area is within a projected area ofthe wave transmission, a single transmission dosage of wave energy maybe used. The transmission dosage can be from a few seconds to 20 minutesor more dependent on the condition. Preferably the waves are generatedfrom an unfocused or focused source. The unfocused waves can bedivergent or near planar and having a low-pressure amplitude and densityin the range of 0.00001 mJ/mm² to 1.0 mJ/mm² or less, most typicallybelow 0.2 mJ/mm². The focused source can use a focused beam of waves orcan optionally use a diffusing lens or have a far-sight focus tominimize if not eliminate having the localized focus point within thetissue. Preferably the focused shock waves are used at a similarlyeffective low energy transmission or alternatively can be at higherenergy but wherein the tissue target site is disposed pre-convergenceinward of the geometric focal point of the emitted wave transmission.Understanding the higher the energy used, the more sensation of pain thepatient may experience.

These shock wave energy transmissions are effective in stimulating acellular response and in some cases, such as unfocused low energy, andeven low energy focused emissions can be accomplished without creatingthe localized hemorrhaging caused by rupturing cavitation bubbles in thetissue of the target site. This effectively insures the patient does nothave to experience the sensation of pain so common in the higher energyfocused wave forms having a focal point at or within the targetedtreatment site.

Accordingly, unless for other reasons such as a trauma or immediatepost-operative shock wave therapy no localized or general anesthesia isrequired.

If the target site is within the body it may be such that the patient orthe generating source must be reoriented relative to the site and asecond, third or more treatment dosage can be administered. The factthat the dosage is at a low energy the common problem of localizedhemorrhaging is reduced making it more practical to administer multipledosages of waves from various orientations to further optimize thetreatment and cellular stimulation of the target site. Heretoforefocused high energy multiple treatments induced pain and discomfort tothe patient. The use of low energy focused or un-focused waves at thetarget site enables multiple sequential treatments. Alternatively, thewave source generators may be deployed in an array wherein the subjectpatient is effectively enveloped or surrounded by a plurality of lowenergy wave source generators which can be simultaneously bombarding thetarget site from multiple directions.

The goal in such treatments is to provide 100 to 3000 acoustic shockwaves at a voltage of 14 kV to 28 kV across a spark gap generator in asingle treatment preferably or one or more adjuvant treatments bytargeting the site impinging the emitted waves on the desiredreflexology target.

The present method, in many cases, does not rely on precise sitelocation per se. The physician's general understanding of the anatomy ofthe patient should be sufficient to locate the reflexology target siteto be treated. The treated area can withstand a far greater number ofshock waves based on the selected energy level being emitted. Forexample, at very low energy levels the stimulation exposure can beprovided over prolonged periods as much as 20 minutes if so desired. Athigher energy levels the treatment duration can be shortened to lessthan a minute, less than a second if so desired. The limiting factor inthe selected treatment dosage is avoidance or minimization of cellhemorrhaging and other kinds of damage to the cells or tissue whilestill providing a stimulating cellular release or activation of VEGF andother growth factors and most importantly to modulate and regulatehormonal secretions from a specific targeted gland by emitting waves toa desired reflexology zone. In other cases where the precise locationmust be known, the use of an applicator acoustic wave emission isdirected by an ultrasound image, preferably the applicator has asoftware program coupled to the imaging device to allow the doctor tovisualize the area being treated. The applicator can be hand held ormanipulated in a fixture, if so desired, in either way the doctor cansee the reflexology zone for any gland to be stimulated and the selectedreflexology zone reflects the path of the wave transmission to modulatethat gland.

A key advantage of the present inventive methodology is that it iscomplimentary to conventional medical procedures. In the case of anyother procedure, the area of the patient can be post operativelybombarded with these low energy waves to stimulate cellular release ofhealing agents and growth factors. Most preferably such patients may beprovided more than one such ESWT treatment with an intervening dwelltime for cellular relaxation prior to secondary and tertiary treatments.

The underlying principle of these shock wave therapy methods is tostimulate the body's own natural healing capability through thereflexology zone. This is accomplished by deploying shock waves tostimulate strong cells in the tissue to activate a variety of responses.The acoustic shock waves transmit or trigger what appears to be acellular communication throughout the entire anatomical structure, thisactivates a generalized cellular response at the treatment site, inparticular, but more interestingly a systemic response in areas moreremoved from the wave form pattern. This is believed to be one of thereasons molecular stimulation can be conducted at threshold energiesheretofore believed to be well below those commonly accepted asrequired. Accordingly, not only can the energy intensity be reduced butalso the number of applied shock wave impulses can be lowered fromseveral thousand to as few as one or more pulses and still yield abeneficial stimulating response. This allows acoustic wave therapies tobe directed to a specific reflexology zone directed toward an endocrinegland being treated with confidence the signal will be fed back to theentire system via the pituitary gland (hypophysis). This use of acousticwave stimulation allows a therapy to be given to modulate and adjustglandular secretions of hormones to be regulated and adjusted to achievea desired adjustment, for example if too low to increase specificsecretions, if too high to lessen these secretions.

The biological model motivated the design of sources with low pressureamplitudes and energy densities. First: spherical waves generatedbetween two tips of an electrode; and second: nearly even wavesgenerated by generated by generalized parabolic reflectors. Third:divergent shock front characteristics are generated by an ellipsoidbehind F2. Unfocused sources are preferably designed for extended twodimensional areas/volumes like skin. The unfocused sources can provide adivergent wave pattern or a nearly planar wave pattern and can be usedin isolation or in combination with focused wave patterns yielding to animproved therapeutic treatment capability that is non-invasive with fewif any disadvantageous contraindications. Alternatively, a focused waveemitting treatment may be used wherein the focal point extends to thedesired reflexology zone or site, preferably at or beyond the targetreflexology treatment site within or even potentially external to thepatient. In any event, the beam of acoustic waves transmitted needs toproject in a large enough reflexology zone or area to stimulate ormodulate the gland. This results in the reduction of or elimination of alocalized intensity zone with associated noticeable pain effect whileproviding a wide or enlarged treatment volume at a variety of depthsmore closely associated with high energy focused wave treatment. Theutilization of a diffuser type lens or a shifted far-sighted focal pointfor the ellipsoidal reflector enables the spreading of the wave energyto effectively create a convergent but off target focal point. Thisinsures less tissue trauma while insuring cellular stimulation toenhance the healing process.

This method of treatment has the steps of, locating a reflexologytreatment site or zone, generating either focused shock waves orunfocused shock waves, of directing these shock waves to the treatmentsite; and applying a sufficient number of these shock waves to induceactivation of one or more growth factor thereby inducing or acceleratinga modulated adjustment to achieve a proper regulated glandular response.

The unfocused shock waves can be of a divergent wave pattern or nearplanar pattern preferably of a low peak pressure amplitude and density.Typically, the energy density values range as low as 0.000001 mJ/mm² andhaving a high end energy density of below 1.0 mJ/mm², preferably 0.40mJ/mm² or less, more preferably 0.20 mJ/mm² or less. The peak pressureamplitude of the positive part of the cycle should be above 1.0 and itsduration is below 1-3 microseconds.

The treatment depth can vary from the surface to the full depth of thehuman or animal torso and the treatment site can be defined by a muchlarger treatment area than the 0.10-3.0 cm² commonly produced by focusedwaves. The above methodology is particularly well suited for surface aswell as sub-surface soft tissue treatments in a reflexology zone.

An exemplary treatment protocol could have emitted shock waves in abroad range of 0.01 mJ/mm² to 3.0 mJ/mm² and 200-2500 pulses pertreatment with a treatment schedule of 1-3 weekly treatments untilsymptoms reduce. This can be repeated as symptoms reoccur or continueweekly as a preventative.

The above methodology is valuable in generation of tissue,vascularization and may be used in combination with stem cell therapiesas well as regeneration of tissue and vascularization.

The following invention description first provides a detailedexplanation of acoustic shock waves, as illustrated in FIGS. 1-9. Asused herein an acoustic shock wave is an asymmetric wave with anexceptionally rapid peak rise time and slower return time from the peakamplitude. Historically, these acoustic shock waves were first usedmedically to destroy kidney stones. The wave patterns were directed to afocal point with ah a relatively high energy to blast the concrementsinto small urinary tract passable fragments.

A whole class of acoustic shock waves for medical treatments were laterdiscovered that employed low energy acoustic shock waves. These lowenergy acoustic shock waves maintained the asymmetric wave profile, butat much lower energies as described in US2006/0100550 which isincorporated herein in its entirety.

These low energy acoustic shock waves advantageously could stimulate asubstance without requiring a focused beam. The advantage of such anunfocused beam was the acoustic wave could be directed to pass throughtissue without causing any cell rupturing which would be evidenced by alack of a hematoma or bruising. This use of unfocused, low energyacoustic shock waves provided an ability to treat a large volume oftissue virtually painlessly.

The use of low energy acoustic shock waves that employ a focused beamhas been spurred on as a viable alternative to the unfocused low energyshock waves because the focal point being of a small point of energy haslittle or a small region of cell damage as the remaining portions of thewave pattern can provide a stimulating effect similar to the unfocusedshock waves. Basically, the effect is the same with the users of focusedwaves achieving the benefits of the unfocused waves, but with a focalpoint of peak energy in a tiny localised region. So, for purposes of thepresent invention, the use of “soft waves” those defined by low energybeams will be applicable to both focused and unfocused beams o acousticshock waves for the present invention.

One last and significant point that the reader must appreciate is thatan “acoustic shock wave” is not an “ultrasound wave”. Sonic orultrasound waves are generated with a uniform and symmetrical wavepattern similar to a sinusoidal wave. This type of sonic wave causes asheer action on tissue as evidenced by a generation of heat within thetissue, for this reason, the use of sonic waves of the ultrasonic typeare not considered as efficient in cell survivability rates.

The present preferred invention avoids the use of such cell damagingsonic waves, most particularly in treating glands via a targetedreflexology zone.

With reference to FIGS. 1-9, a variety of schematic views of acousticshock waves are described. The following description of the properamplitude and pressure pulse intensities of the shock waves 200 areprovided below along with a description of how the shock waves actuallyfunction and have been taken from the co-pending application of thepresent inventors and replicated herein as described below. For thepurpose of describing the shock waves 200 were used as exemplary and areintended to include all of the wave patterns discussed in the figures aspossible treatment patterns.

FIG. 1 is a simplified depiction of a pressure pulse/shock wave (PP/SW)generator, such as a shock wave head, showing focusing characteristicsof transmitted acoustic pressure pulses. Numeral 1 indicates theposition of a generalized pressure pulse generator, which generates thepressure pulse and, via a focusing element, focuses it outside thehousing to treat diseases. The affected tissue or organ is generallylocated in or near the focal point which is located in or near position6. At position 17 a water cushion or any other kind of exit window forthe acoustical energy is located.

FIG. 2 is a simplified depiction of a pressure pulse/shock wavegenerator, such as a shock wave head, with plane wave characteristics.Numeral 1 indicates the position of a pressure pulse generator accordingto the present invention, which generates a pressure pulse which isleaving the housing at the position 17, which may be a water cushion orany other kind of exit window. Somewhat even (also referred to herein as“disturbed”) wave characteristics can be generated, in case a paraboloidis used as a reflecting element, with a point source (e.g. electrode)that is located in the focal point of the paraboloid. The waves will betransmitted into the patient's body via a coupling media such as, e.g.,ultrasound gel or oil and their amplitudes will be attenuated withincreasing distance from the exit window 17.

FIG. 3 is a simplified depiction of a pressure pulse shock wavegenerator (shock wave head) with divergent wave characteristics. Thedivergent wave fronts may be leaving the exit window 17 at point 11where the amplitude of the wave front is very high. This point 17 couldbe regarded as the source point for the pressure pulses. In FIG. 3 thepressure pulse source may be a point source, that is, the pressure pulsemay be generated by an electrical discharge of an electrode under waterbetween electrode tips. However, the pressure pulse may also begenerated, for example, by an explosion, referred to as a ballisticpressure pulse. The divergent characteristics of the wave front may be aconsequence of the mechanical setup.

This apparatus, in certain embodiments, may be adjusted/modified/or thecomplete shock wave head or part of it may be exchanged so that thedesired and/or optimal acoustic profile such as one having wave frontswith focused, planar, nearly plane, convergent or divergentcharacteristics can be chosen.

A change of the wave front characteristics may, for example, be achievedby changing the distance of the exit acoustic window relative to thereflector, by changing the reflector geometry, by introducing certainlenses or by removing elements such as lenses that modify the wavesproduced by a pressure pulse/shock wave generating element. Exemplarypressure pulse/shock wave sources that can, for example, be exchangedfor each other to allow an apparatus to generate waves having differentwave front characteristics are described in detail below.

In one embodiment, mechanical elements that are exchanged to achieve achange in wave front characteristics include the primary pressure pulsegenerating element, the focusing element, the reflecting element, thehousing and the membrane. In another embodiment, the mechanical elementsfurther include a closed fluid volume within the housing in which thepressure pulse is formed and transmitted through the exit window.

In one embodiment, the apparatus of the present invention is used incombination therapy. Here, the characteristics of waves emitted by theapparatus are switched from, for example, focused to divergent or fromdivergent with lower energy density to divergent with higher energydensity. Thus, effects of a pressure pulse treatment can be optimized byusing waves having different characteristics and/or energy densities,respectively.

While the above described universal toolbox of the various types ofacoustic shock waves and types of shock wave generating heads providesversatility, the person skilled in the art will appreciate thatapparatuses that produce low energy or soft acoustic shock waves having,for one example, nearly plane characteristics, are less mechanicallydemanding and fulfill the requirements of many users.

As the person skilled in the art will also appreciate that embodimentsshown in the drawings are independent of the generation principle andthus are valid for not only electro-hydraulic shock wave generation butalso for, but not limited to, PP/SW generation based on electromagnetic,piezoceramic and ballistic principles. The pressure pulse generatorsmay, in certain embodiments, be equipped with a water cushion thathouses water which defines the path of pressure pulse waves that is,through which those waves are transmitted. In a preferred embodiment, apatient is coupled via ultrasound gel or oil to the acoustic exit window(17), which can, for example, be an acoustic transparent membrane, awater cushion, a plastic plate or a metal plate.

FIG. 4a is a simplified depiction of the pressure pulse/shock wavegenerator (shock wave head) having as focusing element an ellipsoid(30). Thus, the generated waves are focused at (6).

FIG. 4b is a simplified depiction of the pressure pulse/shock wavegenerator (shock wave head) having as a focusing element an paraboloid(y2=2px). Thus, the characteristics of the wave fronts generated behindthe exit window (33, 34, 35, and 36) are disturbed plane (“parallel”),the disturbance resulting from phenomena ranging from electrode burndown, spark ignition spatial variation to diffraction effects. However,other phenomena might contribute to the disturbance.

FIG. 4c is a simplified depiction of the pressure pulse/shock wavegenerator (shock wave head) having as a focusing element a generalizedparaboloid (yn=2px, with 1.2<n<2.8 and n≠2). Thus, the characteristicsof the wave fronts generated behind the exit window (37, 38, 39, and 40)are, compared to the wave fronts generated by a paraboloid (y2=2px),less disturbed, that is, nearly plane (or nearly parallel or nearly even(37, 38, 39, 40)). Thus, conformational adjustments of a regularparaboloid (y2=2px) to produce a generalized paraboloid can compensatefor disturbances from, e.g., electrode burn down. Thus, in a generalizedparaboloid, the characteristics of the wave front may be nearly planedue to its ability to compensate for phenomena including, but notlimited to, burn down of the tips of the electrode and/or fordisturbances caused by diffraction at the aperture of the paraboloid.For example, in a regular paraboloid (y2=2px) with p=1.25, introductionof a new electrode may result in p being about 1.05. If an electrode isused that adjusts itself to maintain the distance between the electrodetips (“adjustable electrode”) and assuming that the electrodes burn downis 4 mm (z=4 mm), p will increase to about 1.45. To compensate for thisburn down, and here the change of p, and to generate nearly plane wavefronts over the life span of an electrode, a generalized paraboloidhaving, for example n=1.66 or n=2.5 may be used. An adjustable electrodeis, for example, disclosed in U.S. Pat. No. 6,217,531.

FIG. 4d shows sectional views of a number of paraboloids. Numeral 62indicates a paraboloid of the shape y2=2px with p=0.9 as indicated bynumeral 64 at the x axis which specifies the p/2 value (focal point ofthe paraboloid). Two electrode tips of a new electrode 66 (inner tip)and 67 (outer tip) are also shown in the Figure. If the electrodes arefired and the tips are burning down the position of the tips change, forexample, to position 68 and 69 when using an electrode which adjusts itsposition to compensate for the tip burn down. In order to generatepressure pulse/shock waves having nearly plane characteristics, theparaboloid has to be corrected in its p value. The p value for theburned down electrode is indicate by 65 as p/2=1. This value, whichconstitutes a slight exaggeration, was chosen to allow for an easierinterpretation of the Figure. The corresponding paraboloid has the shapeindicated by 61, which is wider than paraboloid 62 because the value ofp is increased. An average paraboloid is indicated by numeral 60 inwhich p=1.25 cm. A generalized paraboloid is indicated by dashed line 63and constitutes a paraboloid having a shape between paraboloids 61 and62. This particular generalized paraboloid was generated by choosing avalue of n 2 and a p value of about 1.55 cm. The generalized paraboloidcompensates for different p values that result from the electrode burndown and/or adjustment of the electrode tips.

FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shockwave generator (43) (shock wave head) and a control and power supplyunit (41) for the shock wave head (43) connected via electrical cables(42) which may also include water hoses that can be used in the contextof the present invention. However, as the person skilled in the art willappreciate, other set-ups are possible and within the scope of thepresent invention.

FIG. 6 is a simplified depiction of the pressure pulse/shock wavegenerator (shock wave head) having an electromagnetic flat coil 50 asthe generating element. Because of the plane surface of the acceleratedmetal membrane of this pressure pulse/shock wave generating element, itemits nearly plane waves which are indicated by lines 51. In shock waveheads, an acoustic lens 52 is generally used to focus these waves. Theshape of the lens might vary according to the sound velocity of thematerial it is made of. At the exit window 17 the focused waves emanatefrom the housing and converge towards focal point 6.

FIG. 7 is a simplified depiction of the pressure pulse/shock wavegenerator (shock wave head) having an electromagnetic flat coil 50 asthe generating element. Because of the plane surface of the acceleratedmetal membrane of this generating element, it emits nearly plane waveswhich are indicated by lines 51. No focusing lens or reflecting lens isused to modify the characteristics of the wave fronts of these waves,thus nearly plane waves having nearly plane characteristics are leavingthe housing at exit window 17.

FIG. 8 is a simplified depiction of the pressure pulse/shock wavegenerator (shock wave head) having an piezoceramic flat surface withpiezo crystals 55 as the generating element. Because of the planesurface of this generating element, it emits nearly plane waves whichare indicated by lines 51. No focusing lens or reflecting lens is usedto modify the characteristics of the wave fronts of these waves, thusnearly plane waves are leaving the housing at exit window 17. Emittingsurfaces having other shapes might be used, in particular curvedemitting surfaces such as those shown in FIGS. 4a to 4c as well asspherical surfaces. To generate waves having nearly plane or divergentcharacteristics, additional reflecting elements or lenses might be used.The crystals might, alternatively, be stimulated via an electroniccontrol circuit at different times, so that waves having plane ordivergent wave characteristics can be formed even without additionalreflecting elements or lenses.

FIG. 9 is a simplified depiction of the pressure pulse/shock wavegenerator (shock wave head) comprising a cylindrical electromagnet as agenerating element 53 and a first reflector having a triangular shape togenerate nearly plane waves 54 and 51. Other shapes of the reflector oradditional lenses might be used to generate divergent waves as well.

FIG. 10 shows an exemplary shock wave device generator or source 1 witha control and power supply 41 connected to a hand-held applicator shockwave head 43 via a flexible hose 42 with fluid conduits. The illustratedshock wave applicator 43 has a flexible membrane at an end of theapplicator 43 which transmits the acoustic waves when coupled to theskin by using a fluid or acoustic gel. As shown, this type of applicator43 has a hydraulic spark generator using either focused or unfocusedshock waves, preferably in a low energy level, less than the range of0.01 mJ/mm² to 0.3 mJ/mm². The flexible hose 42 is connected to a fluidsupply that fills the applicator 43 and expands the flexible membranewhen filled. Alternatively, a ballistic, piezoelectric or sphericalacoustic shock wave device can be used to generate the desired waves.

FIG. 11 is a perspective view of a foot of a patient whose reflexologyzone or target 100 is being treated. A shock wave applicator head 43 isbrought into contact with the skin Ps preferably an acoustic gel is usedto enhance the transmission of the shock waves 200 through the skin Ps.The shock wave applicator head 43 can be hand held and manipulatedacross the skin Ps to drive the shock waves 200 in the direction theshock wave head 43 is pointed to activate a stimulating response throughthe reflexology zone 100. As illustrated, the device shown is anelectrohydraulic acoustic shock wave generator, however, other devicesthat generate acoustic shock waves can be used. Ultrasonic devices maybe considered, but there is no data to support a sinusoidal wave formwould work and therefore not considered as effective as the asymmetricwave generators. The acoustic shock waves activate a cellular responsewithin the reflexology treatment site. This response or stimulationcauses an increase of nitric oxide and a release of a variety of growthfactors such as VEGF. As shown, the flexible membrane is protrudingoutward and the applicator 43 has been filled with fluid, thetransmission or emission of acoustic shock waves 200 is directed towardsthe reflexology zone 100. In order to accomplish a good transmission, itis important the flexible membrane be pressed against the patient's skinPs and as indicated coupling gels may be used. The zone 100, asillustrated, is the reflexology zone for the pancreas which is a regionof the foot located in a middle of an inside arch of each foot. Bytransmitting the shock waves 200 to the zone 100, is it believed that amodulation of the secretions from the pancreas can be made. Thismodulation or adjustment is achieved by transmitting the acoustic waves200 at low energy directly onto the zone 100. The treatment achieves oneor more of a) modulating blood sugar levels, b) stimulating insulinproduction levels or c) normalizing A1C levels. The modulated responseis one of an adjustment in blood sugar levels or insulin production andrelease or normalizing A1C levels which increases low level output,decreases high level output or stabilizes erratic output; It is believedthat a single treatment of the zone 100 will achieve the desiredmodulation. However, repeated treatments may be administered to helpmaintain and control this secretion level of these hormones. Havingachieved a scheduled pattern of treatments, it is possible to achieveregulation of this gland without the use of drugs or other stimulants.

In practicing the present invention by using the foot's reflexology zoneto treat a type 1 diabetic, the inventors found the following resultswere achieved. Prior to treatment, the patient had A1C erratic levelswith spikes, low blood sugar and evidence of no insulin production.After repeated treatments, the same patient exhibited modulated bloodsugar levels indicating the pancreas had begun producing insulin at itis believed normal secretion levels and the A1C levels had no erraticspikes. This is believed to be a major breakthrough for Type 1 diabeticswho do not exhibit any insulin production from the pancreas. It istherefore believed this may be an effective Type 1 treatment if not acomplete cure for this condition.

With reference to FIG. 12, a view of a hand of a patient whosereflexology zone 100 is being treated with acoustic shock waves 200 isillustrated. In this illustration, it is important to note that theapplicator 43 presses against the skin Ps of the hand in the reflexologyzone 100 for the pancreas which is a region of the right hand in thefatty part below the index finger and a region of the left hand belowthe middle finger close to the wrist.

With reference to FIG. 13, a reflexology foot chart is shown detailingthe various zones that correspond to organs, glands etc. of the body.

With reference to FIG. 14, a reflexology hand chart is shown detailingthe various zones that correspond to organs, glands etc. of the body.

The transmission of the shock waves 200 is preferred of a low energydensity of 0.2 mJ/mm² whether using focused or unfocused shock waves.The acoustic shock waves pulse rapidly through the cells penetrating thecell membrane extremely rapidly due to the rapid rise to peak time andpass through exiting slower due to the slower return from peakamplitude. This asymmetric wave pattern rapidly compresses each cell onentry and slow decompresses the cell as it exits. This effectivesqueezing of each cell is believed to cause the release of growthfactors such as VEGF and others and also creates nitric oxide, allbeneficial to new blood vessel formation. This occurs as a transmissionacross the cell membranes without rupturing the native cells.

Furthermore, such acoustic shock wave forms can be used in combinationwith drugs, chemical treatments, irradiation therapy or even physicaltherapy and when so combined the stimulated cells will more rapidlyassist the body's natural healing response and thus overcomes theotherwise potentially tissue damaging effects of these complimentaryprocedures.

The present invention provides an apparatus for an effective treatmentof indications, which benefit from high or low energy pressurepulse/shock waves having focused or unfocused, nearly plane, convergentor even divergent characteristics. With an unfocused wave having nearlyplane, plane, convergent wave characteristic or even divergent wavecharacteristics, the energy density of the wave may be or may beadjusted to be so low that side effects including pain are very minor oreven do not exist at all.

In certain embodiments, the apparatus of the present invention is ableto produce waves having energy density values that are below 0.1 mJ/mm²or even as low as 0.000 001 mJ/mm². In a preferred embodiment, those lowend values range between 0.1-0.001 mJ/mm². With these low energydensities, side effects are reduced and the dose application is muchmore uniform. Additionally, the possibility of harming surface tissue isreduced when using an apparatus of the present invention that generatesunfocused waves having planar, nearly plane, convergent or divergentcharacteristics and larger transmission areas compared to apparatusesusing a focused shock wave source that need to be moved around to coverthe affected area. The apparatus of the present invention also may allowthe user to make more precise energy density adjustments than anapparatus generating only focused shock waves, which is generallylimited in terms of lowering the energy output. Nevertheless, in somecases the first use of a high energy focused shock wave targeting atreatment zone may be the best approach followed by a transmission oflower energy unfocused wave patterns.

In the use of reflexology zones as the pathway or gate to controlglandular response, the present invention has actual empirical datashowing the effectiveness in the zone directed to the pancreas. It istherefore further believed that similar modulation and beneficialadjustment can be achieved at other reflexology zones for stimulating,modulating or adjusting other glands or organs such as the liver, kidneyor any of those indicated in FIG. 13 for the foot zones and FIG. 14 forthe hand zones. It is further believed that the hybrid Eastern medicalacupuncture treatments or massages historically used are far lesseffective and less reliable than the results achieved by the deepertissue penetrating transmission that are achieved by acoustic shock wavetherapy applied to these reflexology zones. Historically, the inventorinitially targeted treatment locations at the organ as in the U.S. Pat.No. 7,988,648 B2, but the present invention has found the use of thereflexology zones has achieved unexpected far superior results.

It will be appreciated that the apparatuses and processes of the presentinvention can have a variety of embodiments, only a few of which aredisclosed herein. It will be apparent to the artisan that otherembodiments exist and do not depart from the spirit of the invention.Thus, the described embodiments are illustrative and should not beconstrued as restrictive.

Variations in the present invention are possible in light of thedescription of it provided herein. While certain representativeembodiments and details have been shown for the purpose of illustratingthe subject invention, it will be apparent to those skilled in this artthat various changes and modifications can be made therein withoutdeparting from the scope of the subject invention. It is, therefore, tobe understood that changes can be made in the particular embodimentsdescribed which will be within the full intended scope of the inventionas defined by the following appended claims.

What is claimed is:
 1. A treatment method of treating a human patientexhibiting high or low blood sugar levels, high or low insulinproduction or abnormal A1C levels by achieving one or more of a)modulating blood sugar levels, b) stimulating insulin production levelsor c) normalizing A1C levels comprises the steps of: activating anacoustic shock wave generator with a shock wave applicator to emitacoustic shock waves; administering acoustic shock waves to a targetsite which is a reflexology zone of a patient, wherein the reflexologyzone underlies the patient's skin in a region of a hand or foot and thereflexology zone lies in the path of the emitted shock waves by:subjecting the reflexology zone to acoustic shock waves stimulating apatient's tissue at a reflexology location corresponding to a specificgland by emitting the acoustic shock waves to the tissue of the hand orfoot at the reflexology zone is in the path of the emitted shock wavesfrom the shock wave applicator causing the specific gland-to have amodulated response wherein the modulated response is one or more of anadjustment in blood sugar levels or insulin production and a release ornormalizing A1C levels wherein the modulated response increases lowlevel insulin output, decreases high level insulin output or stabilizeserratic insulin output; and wherein the emitted acoustic shock waves arefocused or unfocused acoustic shock waves, the emitted acoustic shockwaves comprise an energy density of 0.00001 mJ/mm² to 1.0 mJ/mm² and anamplitude above 0.1 MPa and rise times of the amplitude are below 100nano-seconds with a duration of the acoustic shock waves being below 3micro-seconds for a positive part of a cycle.
 2. The treatment method ofclaim 1, wherein the shock wave generator is acoustically coupled to thepatient's skin using a coupling gel or liquid.
 3. The treatment methodof claim 1, wherein the reflexology zone for a pancreas is a region ofthe foot located in a middle of an inside arch of each foot.
 4. Thetreatment method of claim 1, wherein the reflexology zone for a pancreasis a region of a right hand in a fatty part below an index finger of theright hand and a region of a left hand below a middle finger of the lefthand close to a wrist of the left hand.
 5. The treatment method of claim1, further comprising the step of stimulating of the patient's tissuewith a sufficient amount of acoustic shock waves to stimulate a pancreasto cause a release of nitric oxide, secretion of digestive enzymes,hormones and insulin.
 6. The treatment method of claim 5, furthercomprising the step of stimulating of the pancreas with a sufficientamount of acoustic shock waves cause a release of growth factorsincluding vascular endothelial growth factor (VEGF).
 7. The treatmentmethod of claim 6, further comprising the step of stimulating of thepancreas with a sufficient amount of acoustic shock waves cause newblood vessels to be created to increase vascularization.
 8. Thetreatment method of claim 1, is repeated one or more times.
 9. Thetreatment method of claim 8, wherein the number of repeated treatmentsoccur on a schedule over a period of three or more weeks, and treatmentsis repeated over time as a risk prevention protocol over longerdurations of time between repeated treatments.
 10. The treatment methodof claim 1, wherein the emitted acoustic shock waves are low energy softwaves.
 11. The treatment method of claim 10, wherein the low energy softwaves have an energy density in a range of 0.01 mJ/mm² to 0.4 mJ/mm².12. The treatment method of claim 11, wherein the low energy soft waveshave an energy density in the range of 0.04 mJ/mm² to 0.3 mJ/mm². 13.The treatment method of claim 1, wherein each subjected reflexology zonereceives between 100 and 2000 acoustic shock waves per therapy session.14. The treatment method of claim 1, wherein the modulated blood sugarlevel response is a decrease in the blood sugar level wherein thepatient was exhibiting high levels of blood sugar.
 15. The treatmentmethod of claim 1, wherein the response to stimulating insulinproduction is an increase in insulin release wherein the patient wasexhibiting low levels of insulin production.
 16. The treatment method ofclaim 1, wherein the response of normalizing A1C levels is a decrease inspikes wherein the patient was exhibiting high levels of A1C spikes. 17.The treatment method of claim 1, wherein the acoustic shock waves arespherical, radial, convergent, divergent, planar, near planar, focusedor unfocused from a source with or without a lens that is one ofelectrohydraulic, electromagnetic, piezoelectric, ballistic or waterjets configured to produce an acoustic shock wave and wherein theacoustic shock waves are administered invasively or noninvasively. 18.The treatment method of claim 1, wherein the emitted acoustic shockwaves are spherical, radial, convergent, divergent, planar, near planar,focused or unfocused from a source with or without a lens that is one ofelectrohydraulic, electromagnetic, piezoelectric, ballistic or waterjets configured to produce an acoustic shock wave and wherein theacoustic shock waves are administered noninvasively.
 19. A treatmentmethod of treating a human patient exhibiting high or low blood sugarlevels by achieving modulating blood sugar levels comprises the stepsof: activating an acoustic shock wave generator with a shock waveapplicator to emit acoustic shock waves; administering acoustic shockwaves to a target site which is a reflexology zone of a patient, whereinthe reflexology zone underlies the patient's skin in a region of a handor foot and the reflexology zone lies in the path of the emitted shockwaves by: subjecting the reflexology zone to acoustic shock wavesstimulating a patient's tissue at a reflexology location correspondingto a specific gland by emitting the acoustic shock waves to the tissueof the hand or foot at the reflexology zone is in the path of theemitted shock waves from the shock wave applicator causing the specificgland-to have a modulated response wherein the modulated response is anadjustment in blood sugar levels wherein the modulated blood sugar levelresponse is a decrease in the blood sugar level wherein the patient wasexhibiting high levels of blood sugar; and wherein the emitted acousticshock waves are focused or unfocused acoustic shock waves, the emittedacoustic shock waves comprise an energy density of 0.00001 mJ/mm² to 1.0mJ/mm² and an amplitude above 0.1 MPa and rise times of the amplitudeare below 100 nano-seconds with a duration of the acoustic shock wavesbeing below 3 micro-seconds for a positive part of a cycle.
 20. Atreatment method of treating a human patient exhibiting high or lowinsulin production by stimulating insulin production levels comprisesthe steps of: activating an acoustic shock wave generator with a shockwave applicator to emit acoustic shock waves; administering acousticshock waves to a target site which is a reflexology zone of a patient,wherein the reflexology zone underlies the patient's skin in a region ofa hand or foot and the reflexology zone lies in the path of the emittedshock waves by: subjecting the reflexology zone to acoustic shock wavesstimulating a patient's tissue at a reflexology location correspondingto a specific gland by emitting acoustic shock waves to the tissue ofthe hand or foot at the reflexology zone is in the path of the emittedshock waves from the shock wave applicator causing the specific gland-tohave a modulated response wherein the modulated response is anadjustment in insulin production wherein the response to stimulatinginsulin production is an increase in insulin release wherein the patientwas exhibiting low levels of insulin production; and wherein the emittedacoustic shock waves are focused or unfocused acoustic shock waves, theemitted acoustic shock waves comprise an energy density of 0.00001mJ/mm² to 1.0 mJ/mm² and an amplitude above 0.1 MPa and rise times ofthe amplitude are below 100 nano-seconds with a duration of the acousticshock waves being below 3 micro-seconds for a positive part of a cycle.21. A treatment method of treating a human patient exhibiting abnormalA1C levels by normalizing A1C levels comprises the steps of: activatingan acoustic shock wave generator with a shock wave applicator to emitacoustic shock waves; administering acoustic shock waves to a targetsite which is a reflexology zone of a patient, wherein the reflexologyzone underlies the patient's skin in a region of a hand or foot and thereflexology zone lies in the path of the emitted shock waves by:subjecting the reflexology zone to acoustic shock waves stimulating apatient's tissue at a reflexology location corresponding to a specificgland by emitting the acoustic shock waves to the tissue of the hand orfoot at the reflexology zone is in the path of the emitted shock wavesfrom the shock wave applicator causing the specific gland-to have amodulated response wherein the modulated response is normalizing A1Clevels wherein the response of normalizing A1C levels is a decrease inspikes wherein the patient was exhibiting high levels of A1C spikes; andwherein the emitted acoustic shock waves are focused or unfocusedacoustic shock waves, the emitted acoustic shock waves comprise anenergy density of 0.00001 mJ/mm² to 1.0 mJ/mm² and an amplitude above0.1 MPa and rise times of the amplitude are below 100 nano-seconds witha duration of the acoustic shock waves being below 3 micro-seconds for apositive part of a cycle.